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Harro Hofliger Reduces Risk in Pharmaceutical Manufacturing Equipment with Dyadem
Date:7/30/2008

top priority and FMEA-Med makes it easier to meet our standards. Our customers also like the risk management service that we offer," said Jan Schikora, Head of Quality Assurance & Validation, Harro Hofliger. "Although our quality levels have remained constant, now the process of maintaining the standard is far less painful for us internally."

Before investing in Dyadem's FMEA-Med software, Harro Hofliger used standard spreadsheets for its risk analysis and reporting, requiring hours of hand-coding and formatting, thereby slowing the analysis process considerably. The cost and time savings were the biggest benefits accrued by Harro Hofliger using Dyadem's FMEA-Med. The time engineers spent on documentation decreased from one week to one day, for each of its projects.

"We run multiple risk assessments for multiple customers on any given day. Each customer uses different notations and rating systems for the evaluation of critical processes, so flexibility of the software was a key issue," Schikora said. "Dyadem was the only vendor that offered the flexibility that we required upfront. All of Dyadem's competitors charge expensive consulting and servicing fees for providing comparable flexibility."

"Maintaining quality and minimizing production errors is especially crucial in the pharmaceutical industry given that a production error could mean the difference between life and death," said Kevin North, president and CEO of Dyadem. "While minimizing risk is always difficult, doing so within resource constraints can be even more challenging. Our goal with FMEA-Med was to create a software solution that automates quality analysis for better compliance and better transparency and seeing Harro Hofliger's results validates our strategy."

About Dyadem

Founded in 1993, Dyadem is the market leader in Quality Lifecycle Management and Risk Lifecycle Management solutions. Dyadem provides software and services that empower companies to manage quality,
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SOURCE Dyadem
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